Ahead of the Investigative & Preclinical Toxicology Summit 2026, the dedicated Pre‑Conference Workshop Day is emerging as one of the most highly anticipated elements of the meeting, drawing senior toxicology, safety, and regulatory leaders seeking practical, discussion‑led insight.
Designed to move beyond traditional presentations, the workshop day brings attendees into focused, interactive sessions with experts from Daiichi Sankyo, Biogen, and AstraZeneca, addressing the most pressing challenges in predictive toxicology and IND strategy.
Workshop A:
Navigating Global Regulatory Expectations for Preclinical Toxicology & IND Success
Presented by: Marc DeCristofaro, Director, Medicinal Safety at Daiichi Sankyo & Colin Choi, Associate Scientific Director at Biogen
This session focuses on strengthening preclinical toxicology packages to meet evolving global regulatory expectations. Experts from Daiichi Sankyo and Biogen will lead discussions on:
- How FDA and international regulatory views on NAMs, in vitro models, and AI‑enabled approaches are evolving
- Real‑world IND case studies, including approaches that have succeeded and those that have faced regulatory pushback
- Building multi‑market IND strategies from the outset
- When and how to engage regulators to de‑risk development timelines
Workshop B:
Enhancing Translation of Toxicity Across Preclinical & Clinical Teams
Presented by: Shimeng Liu, Senior Scientist & John Kwon, Associate Director at AstraZeneca
Led by experts from AstraZeneca, this session addresses the challenge of translating complex preclinical safety data into meaningful clinical insight, with a focus on:
- Defining fit‑for‑purpose validation for advanced in vitro models
- Bridging mechanistic toxicology insights with regulatory and clinical decision‑making
- Addressing modality‑specific challenges, including ADCs and complex biologics
- Leveraging advanced systems such as organoids to improve early risk prediction and clinical translation
The Pre‑Conference Workshop Day is designed for professionals responsible for IND strategy, model validation, and translating preclinical safety data into confident development decisions, setting a strong foundation for the main summit program.
To learn more about the workshops or to view the full agenda, visit: https://ter.li/rbaxrk
To participate in the Pre‑Conference Workshop Day and main summit, register here: https://ter.li/wtmncs